Quality

Quality Policy

Our mission is to create a world class, competitive endovascular intervention business – we will achieve this by consistently delivering excellent quality products and service meeting the needs and expectations of our customers.

Ensuring patient safety at all times is our number one priority and this will focus our efforts to continually improve our quality system and processes.

We are committed to the highest quality standards in everything we do and will comply with all of the relevant regulatory requirements.

 

Quality Accreditation

ArraVasc Ltd. has implemented a process-based quality management system in compliance with the requirements of ISO 13485; Medical devices – Quality management systems – Requirements for regulatory purposes and Annex II of the European Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. ISO 13485 is the international standard that defines the requirements for managing the design and manufacture of medical devices.

 

Certificates